Orgalutran 0.25 mg/0.5 ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Orgalutran 0.25 mg/0.5 ml solution for injection

ganirelix

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you. It may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if the side effects are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Orgalutran is and what it is used for
2. What you need to know before using Orgalutran
3. How to use Orgalutran
4. Possible side effects
5. How to store Orgalutran
6. Contents of the pack and other information

1. What Orgalutran is and what it is used for

Orgalutran contains the active substance ganirelix and belongs to a group of medicines called “gonadotropin-releasing hormone antagonists” which act against the effects of endogenous gonadotropin-releasing hormone (GnRH). GnRH regulates the release of gonadotropins (luteinizing hormone (LH) and follicle-stimulating hormone (FSH)). Gonadotropins play an important role in human fertility and reproduction. FSH is required in women for the growth and development of follicles in the ovaries. Follicles are small, rounded sacs that contain the eggs. LH is necessary for mature eggs to be released from the ovarian follicles (i.e., ovulation). Orgalutran inhibits the action of GnRH, thereby suppressing the release of LH, in particular.

What Orgalutran is used for

In women undergoing assisted reproductive techniques such as in vitro fertilization (IVF) and other methods, premature ovulation may occasionally occur, which significantly reduces the chance of becoming pregnant. Orgalutran is used to prevent the premature release of LH, which could otherwise cause premature ovulation.

In clinical studies, Orgalutran was used in combination with recombinant follicle-stimulating hormone (FSH) or with corifollitropin alfa, a long-acting follicle-stimulating agent.

2. What you need to know before using Orgalutran

Do not use Orgalutran

• if you are allergic to ganirelix or to any of the other components of this medicine (listed in section 6);
• if you are hypersensitive to gonadotropin-releasing hormone (GnRH) or to its analogues;
• if you have moderate or severe kidney or liver disease;
• if you are pregnant or breastfeeding.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Orgalutran

Allergic reactions

If you have an active allergy, inform your doctor. Your doctor will decide, depending on the severity, whether additional monitoring is required during treatment. Cases of allergic reactions have been observed, even after the first dose.

Allergic reactions, both generalized and local, have been reported, including hives (urticaria), swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing and/or swallowing (angioedema and/or anaphylaxis) (see also section 4). If you experience an allergic reaction, stop using Orgalutran and seek immediate medical assistance.

Ovarian hyperstimulation syndrome (OHSS)

Ovarian hyperstimulation syndrome may develop during or after hormonal stimulation of the ovaries. This syndrome is associated with gonadotropin stimulation procedures. We recommend that you read the package leaflet of the gonadotropin-containing medicine prescribed to you.

Multiple births or birth defects

The incidence of congenital malformations following the use of assisted reproductive techniques may be slightly higher than after spontaneous conceptions. This slightly increased incidence is considered to be related to patient characteristics undergoing fertility treatments (e.g., maternal age, semen characteristics) and the higher incidence of multiple pregnancies observed with assisted reproductive techniques. The incidence of congenital malformations following assisted reproductive techniques using Orgalutran is not different from that observed with other GnRH analogues used in assisted reproductive techniques.

Pregnancy complications

There is a slightly increased risk of ectopic pregnancy (pregnancy outside the uterus) in women with damaged fallopian tubes.

Women weighing less than 50 kg or more than 90 kg

The efficacy and safety of Orgalutran in women weighing less than 50 kg or more than 90 kg have not been established. Consult your doctor for further information.

Children and adolescents

Orgalutran is not appropriate for use in children or adolescents.

Use of Orgalutran with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy, breastfeeding and fertility

Orgalutran is intended for use during controlled ovarian stimulation in assisted reproductive techniques (ART). Do not use Orgalutran during pregnancy or breastfeeding.

Consult your doctor or pharmacist before using this medicine.

Driving and using machines

The effects of this medicine on the ability to drive and use machines have not been studied.

Orgalutran contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per injection; this is essentially "sodium-free".

3. How to use Orgalutran

Follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Orgalutran is used as part of treatment in assisted reproductive techniques (ART), including in-vitro fertilization (IVF).

Ovarian stimulation with follicle-stimulating hormone (FSH) or corifolitropin may begin on the second or third day of your menstruation. Orgalutran (0.25 mg) must be injected once daily just under the skin, starting on the fifth or sixth day of stimulation. Depending on your ovarian response, your doctor may decide to start on another day.

Orgalutran and FSH preparations must not be mixed, even though they should be administered approximately at the same time, injected at different sites.

Daily treatment with Orgalutran should continue until there are enough follicles of adequate size. Final maturation of the oocytes within the follicles can be induced by administering human chorionic gonadotropin (hCG). The interval between two Orgalutran injections and between the last Orgalutran injection and the hCG injection must not exceed 30 hours; otherwise, premature ovulation (i.e., release of the oocytes) may occur. Therefore, if the Orgalutran injection is given in the morning, treatment with Orgalutran must be maintained throughout the gonadotropin treatment period, including on the day ovulation is induced. If the Orgalutran injection is given in the afternoon, the last Orgalutran injection must be administered the afternoon before the day on which ovulation is induced.

Instructions for use

Injection site

Orgalutran is supplied in pre-filled syringes and must be injected slowly just under the skin, preferably in the thigh. Check the solution before use. Do not use the solution if it contains particles or is not clear. You may notice air bubbles in the pre-filled syringe. This is expected and it is not necessary to remove the air bubbles. If you or your partner administer the injections, follow carefully the instructions below. Do not mix Orgalutran with other medicines.

Preparing the injection site

Wash your hands thoroughly with soap and water. The injection site should be cleaned with a disinfectant (e.g., alcohol) to remove bacteria from the surface. Clean an area of about 5 cm around the injection site and allow the disinfectant to dry for at least one minute before injecting.

Inserting the needle

Remove the needle cap. Pinch a large area of skin between your index finger and thumb. Insert the needle at the base of the pinched skin at a 45º angle to the skin surface. The injection site should be varied with each injection.

Checking correct needle placement

Gently pull back the plunger to check whether the needle is correctly placed. If blood enters the syringe, this means the tip of the needle has entered a blood vessel. If this occurs, do not inject Orgalutran; instead, remove the syringe, cover the injection site with a disinfectant swab, and apply pressure; bleeding should stop within one or two minutes. Do not use this syringe and dispose of it properly. Start again with a new syringe.

Injecting the solution

Once the needle is correctly placed, press the plunger slowly and steadily to properly inject the solution and avoid damaging the skin tissue.

Removing the syringe

Remove the syringe quickly and press on the injection site with a disinfectant swab.

Use the pre-filled syringe only once.

If you use more Orgalutran than you should

Consult your doctor.

If you forget to use Orgalutran

If you realize you have forgotten to inject a dose, administer it as soon as possible.

Do not administer a double dose to make up for missed doses.

If the delay is more than 6 hours (thus, the interval between two injections exceeds 30 hours), administer the dose as soon as possible and contact your doctor for advice.

If you stop using Orgalutran

Do not stop using Orgalutran unless instructed by your doctor, as this may affect the outcome of your treatment.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The likelihood of experiencing an adverse effect is classified into the following categories:

Very common: may affect more than 1 in 10 women

• Local skin reactions at the injection site (mainly redness, with or without swelling). Local reactions usually disappear within 4 hours after administration.

Uncommon: may affect up to 1 in 100 women

• Headache
• Nausea
• Malaise

Very rare: may affect up to 1 in 10,000 women

• Allergic reactions have been observed, even after the first dose.

• Rash

• Facial swelling

• Difficulty breathing (dyspnea)

• Swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing and/or swallowing (angioedema and/or anaphylaxis)

• Hives (urticaria)

• Worsening of pre-existing eczema has been reported after the first dose of Orgalutran in one patient.

Additionally, adverse effects related to controlled ovarian hyperstimulation treatment have been observed (such as abdominal pain, ovarian hyperstimulation syndrome (OHSS), ectopic pregnancy (when the embryo develops outside the uterus), and miscarriage (see the package leaflet of the FSH medicine you are using)).

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Orgalutran

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after 'EXP'. The expiry date is the last day of the month indicated.

Do not freeze.

Store in the original packaging to protect from light.

Inspect the syringe before use. The syringe should only be used if the solution is clear and free of particles and the packaging is undamaged.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Orgalutran

• The active substance is ganirelix (0.25 mg in 0.5 ml of solution).
• The other components are acetic acid, mannitol, water for injections. The pH (measure of acidity) may have been adjusted with sodium hydroxide and acetic acid.

Nature of the product and contents of the pack

Orgalutran is a ready-to-use, clear, colourless, aqueous injectable solution administered subcutaneously.

Orgalutran is available in packs of 1 or 5 pre-filled syringes.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

N.V. Organon

Kloosterstraat 6

5349 AB Oss

The Netherlands

Manufacturer

N.V. Organon,

Kloosterstraat 6,

P.O. Box 20,

5340 BH Oss,

The Netherlands.

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet: {month YYYY}.

Detailed information about this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.